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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameaortic valve, prosthesis, percutaneously delivered
PMA NumberP130021
Supplement NumberS002
Date Received02/27/2014
Decision Date06/12/2014
Product Code
NPT[ Registered Establishments with NPT ]
Docket Number 14M-0867
Notice Date 07/08/2014
Advisory Committee Cardiovascular
Clinical Trials NCT01240902
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the medtronic corevalve system. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area <=1. 0 cm2 or aortic valve area index <=0. 6 cm2/m2, a mean aortic valve gradient of >=40 mm hg, or a peak aortic-jet velocity of >=4. 0 m/s) and with native anatomy appropriate for the 23, 26, 29, or 31 mm valve system who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i. E. , society of thoracic surgeons operative risk score >=8% or at a >=15% risk of mortality at 30 days).
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress